Exogenous Surfactant in Very Preterm Neonates in Prevention of Bronchopulmonary Dysplasia

Phase 4

Completed

• Conditions: Infant, Premature, Diseases; Respiratory Distress Syndrome, Newborn; Bronchopulmonary Dysplasia
• Interventions: Other: Air; Drug: Curosurf

• Registration Number: NCT01039285
• Lead Sponsor: Jean Michel Hascoet

Brief Summary

Advances in perinatal care have made it possible to improve the survival of the most immature neonates, but at the cost of an increase in the population at risk of developing bronchopulmonary dysplasia (BPD). Measures that have attempted to limit the development of BPD are not always effective, or related to major side effects. The physiopathological factors that are identified in BPD should, in theory, respond to surfactant. Therefore, the use of an exogenous surfactant in neonates presenting with pulmonary disease requiring mechanical ventilation, leading to a significant risk of BPD, should allow earlier extubation and thus promote pulmonary healing and growth.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2009-12-23
• Study First Submitted QC: 2009-12-23
• Study First Posted: 2009-12-24
• Primary Completion: 2021-09
• Study Completion: 2022-06
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-23
• Last Update Posted: 2022-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

Inclusion Criteria

• any neonate of gestational age less than 33 weeks of amenorrhea still on conventional assisted ventilation or HFOV (High Frequency Oscillatory Ventilation), after 14 ± 2 days of life

Exclusion Criteria

• active infection (CRP > 30 mg/L) not controlled by appropriate antibiotic treatment
• use of corticosteroids in the postnatal period
• significant neurological or malformative disease
• surgical intervention < 72 hours
• refusal of parental approval

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo instillation	Air	2.5 ml/kg of Air will be instilled in the trachea
Surfactant instillation	Curosurf	2.5 ml/kg of Surfactant will be instilled in the trachea

Primary Outcome Measures

Name	Time	Method
duration of assisted ventilation	days	we aim to demonstrate a significant reduction in the duration of assisted ventilation in children presenting with severe respiratory distress at 14+/-2 days of life.

Secondary Outcome Measures

Name	Time	Method
to improve development in stature and weight, psychomotor development, and to reduce respiratory sequelae leading to re-hospitalisation	2 years of age
to improve height development, psychomotor development and respiratory function	7 years of age
to reduce the incidence of BPD	36 weeks post conceptional age
to improve the inflammatory status of the lung and to restore its capacities for healing and growth	one month

Trial Locations

Locations (12)

AP-HP Hopital Port Royal; 🇫🇷 Paris, France

CHU hopital d'enfants; 🇫🇷 Dijon, France

CHU Hopital Nord; 🇫🇷 Amiens, France

CHU Hopital Clemenceau; 🇫🇷 Caen, France

CHI Andre Gregoire; 🇫🇷 Montreuil, France

APHM hopital de la conception; 🇫🇷 Marseille, France

CHU Hopital Gatien de Clocheville; 🇫🇷 Tours, France

CHU; 🇫🇷 Angers, France

CHU Hopital Jeanne de Flandre; 🇫🇷 Lille, France

Centre Hospitalier; 🇫🇷 Lens, France

CHU Hopital de la Croix Rousse; 🇫🇷 Lyon, France

Maternite Regionale Universitaire; 🇫🇷 Nancy, France